在乙型肝炎疫苗在后期试验中未能达到次要目标后，更新2-VBI

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UPDATE 2-VBI's shares plunge after hep B vaccine fails secondary goal in late-stage trial
By Manojna Maddipatla and Tamara Mathias

June 17 (Reuters) - VBI Vaccines Inc said on Monday a late-stage study was unsuccessful in showing two doses of its hepatitis B vaccine were as effective as three doses of an older vaccine from GlaxoSmithKline, sending its shares plunging 66%.

The study tested VBI's Sci-B-Vac against GSK's Engerix-B, a vaccine which was approved in the United States in 1989.

Two doses of Sci-B-Vac did not meet the trial's secondary goal of non-inferiority in all patients aged 18 and above, when compared to three doses of Engerix-B.

This marks a setback for the vaccine that will likely compete with Heplisav-B, a two-dose vaccine from Dynavax Technologies Corp's which gained FDA approval https://www.reuters.com/article/ ... es-up-idUSKBN1D93AN in November 2017.

"Without a two-dose non-inferiority claim on a potential label, it will be difficult for Sci-B-Vac to gain significant share from Heplisav-B, even if its three-dose regimen does enter and compete in some markets," RBC Capital Markets analyst Brian Abrahams said.

Dynavax shares rose 6.4% to $4.06 in afternoon trading.

VBI's trial, however, met its main goals and the company said its two-dose regimen could still hold potential in treating adults younger than 45.

The seroprotection rate, a measure of clinical protection provided by the vaccine, in all patients aged 18 and older who received Sci-B-Vac was 91.4% compared with 76.5% for those who received Engerix-B, the company said.

In harder-to-treat patients aged 45 and older, three doses of Sci-B-Vac was shown to be superior to the same amount of Engerix-B, with 89% protection versus 73%.

"We remain on track to submit applications for regulatory approvals in the U.S., Europe, and Canada beginning mid-year 2020," Chief Executive Officer Jeff Baxter said in a statement.

Baxter added that VBI intended to price the vaccine competitively with Engerix-B.

"We do not see ourselves competing with Engerix-B and GlaxoSmithKline. We rather see this product being complementary," he said.

Sci-B-Vac is also being studied in another late-stage trial, whose results are expected by the year end.

The vaccine is approved in over ten countries including Israel.

Hepatitis B, a viral infection that attacks the liver, is spread by contact with the blood or bodily fluids of an infected person. The World Health Organization estimates 257 million people are living with hepatitis B virus infection.

Hepatitis B vaccines have been available for more than two decades, but infection remains a worldwide issue, largely due to low vaccination rates. (Reporting by Tamara Mathias and Manojna Maddipatla in Bengaluru; Editing by Shailesh Kuber)

StephenW

在乙型肝炎疫苗在后期试验中未能达到次要目标后，更新2-VBI的股价暴跌
由Manojna Maddipatla和Tamara Mathias撰写

6月17日（路透社） -  VBI疫苗公司周一表示，一项晚期研究未能成功显示两剂乙肝疫苗与葛兰素史克的三剂老疫苗一样有效，其股价暴跌66％。

该研究测试了VBI的Sci-B-Vac对抗GSK的Engerix-B，这种疫苗于1989年在美国获得批准。

与三剂Engerix-B相比，两剂Sci-B-Vac在18岁及以上的所有患者中均未达到该试验的非劣效性次要目标。

这标志着疫苗的挫折可能会与来自Dynavax Technologies公司的双剂量疫苗Heplisav-B竞争，后者获得了FDA的批准https://www.reuters.com/article/us-dynavax-techs-fda/dynavaxs 2017年11月，-hepatitis-b-vaccine-fn-on-third-try-shares-up-idUSKBN1D93AN。

“如果没有针对潜在标签的两剂非劣效性声明，Sci-B-Vac很难从Heplisav-B获得大量份额，即使其三剂量方案确实进入某些市场并参与竞争，” RBC Capital Markets分析师Brian Abrahams表示。

Dynavax股价在下午交易中上涨6.4％至4.06美元。

然而，VBI的试验符合其主要目标，该公司表示其两剂量方案仍可用于治疗45岁以下的成年人。

该公司表示，所有接受Sci-B-Vac治疗的18岁及以上患者的血清保护率，即疫苗提供的临床保护措施，为91.4％，而接受Engerix-B治疗的患者为76.5％。

在45岁及以上的难治性患者中，三种剂量的Sci-B-Vac显示优于相同量的Engerix-B，保护率为89％，而73％。

“我们有望在2020年年中开始在美国，欧洲和加拿大提交监管审批申请，”首席执行官杰夫巴克斯特在一份声明中表示。

百特补充说，VBI打算与Engerix-B竞争性地对疫苗定价。

“我们不认为自己会与Engerix-B和GlaxoSmithKline竞争。我们宁愿看到这种产品是互补的，”他说。

Sci-B-Vac也正在另一项后期试验中进行研究，其结果预计将在年底前完成。

疫苗已在包括以色列在内的十多个国家获得批准。

乙型肝炎是一种攻击肝脏的病毒感染，通过接触受感染者的血液或体液而传播。世界卫生组织估计有2.57亿人患有乙型肝炎病毒感染。

乙型肝炎疫苗已有二十多年的历史，但感染仍然是一个世界范围的问题，主要原因是疫苗接种率低。 （Tamara Mathias和Manojna Maddipatla在班加罗尔的报道; Shailesh Kuber的编辑）